A Model‐Informed Drug Discovery and Development Strategy for the Novel Glucose‐Responsive Insulin MK‐2640 Enabled Rapid Decision Making

摘要

A model‐informed drug discovery and development strategy played a key role in the novel glucose‐responsive insulin MK‐2640’s early clinical development strategy and supported a novel clinical trial paradigm to assess glucose responsiveness. The development and application of modeling approaches by leveraging substantial published clinical insulin pharmacokinetic–pharmacodynamic (PKPD) data and emerging preclinical and clinical data enabled rapid quantitative decision making. Learnings can be applied to define PKPD properties of novel insulins that could become therapeutically meaningful for diabetic patients.